omacor medicine Uses, Dosage, Side Effects, Precautions & Warnings

omacor medication >> Generic drug of the therapeutic class: Cardiology and angiology
active principles:Ethyl esters of Omega 3 acids , Including ethyl esters of,Eicosapentaenoic acid ,Docosahexaenoic acid , Containing as an antioxidant:Alpha-tocopherol (E307)

what is omacor used for and indication?

OMACOR, soft capsule belongs to a class of drugs known to lower cholesterol and triglycerides.

This medicine is used:

• as complementary treatment following a heart attack (myocardial infarction), in combination with other medicines.
• in the treatment of certain forms of hypertriglyceridemia (excessive amount of fat in the blood) when a suitable and diligent diet has proved insufficient.

Indication :

Post Myocardial Infarction

Adjuvant therapy for secondary prevention of myocardial infarction, in combination with standard treatments (including statins, antiplatelet agents, beta blockers and angiotensin converting enzyme inhibitors).

Hypertriglyceridemia

• Endogenous hypertriglyceridemia, in addition to a diet whose prescription alone has proved insufficient to provide an adequate response:
  • Type IV monotherapy,
  • Type IIb / III in combination with statins, when triglyceride control is insufficient.

PRESENTATION (S) AVAILABLE FOR OMACOR

3 presentations are available for this drug:

• 1 polyethylene bottle (s) of 28 capsule (s)
• 1 polyethylene bottle (s) of 100 capsule (s)
• 10 polyethylene bottle (s) of 28 capsule (s)

FEATURE	DESCRIPTION
Pharmaceutical class	lipid-lowering
Active substance (s)	for one capsule: ethyl esters of omega-3 acids (1000 mg)
General medicine	no
Pharmaceutical form	soft capsule
Route (s) of administration	oral
Social security reimbursement rate	65%
Laboratory (s)	PIERRE FABRE MEDICINE
Conditions of issue	restricted prescription drug

omacor Dosage

Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.

• Swallow the capsules with a glass of water.
• It is recommended to take the capsules with meals to reduce the risk of digestive disorders.
• Your doctor will decide on the duration of treatment.

Dose to take after a heart attack:

• The usual dose is 1 capsule per day.

Dose to take to treat high triglyceride levels in the blood (too much fat in the blood or hypertriglyceridemia):

• The usual dose recommended by a doctor is 2 capsules per day. If the medicine does not work enough, your doctor may increase the dose to 4 capsules per day.

omacor Contraindications

• Hypersensitivity to the active substance, to soy or to any of the excipients listed in the Composition section.
• Due to the presence of soybean oil, this medication is contraindicated in cases of allergy to peanuts or soya.

How To Take omacor ?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.

• Swallow the capsules with a glass of water.
• It is recommended to take the capsules with meals to reduce the risk of digestive disorders.
• Your doctor will decide the duration of treatment.

how does omacor work?

Pharmacotherapeutic group: Omega-3 triglycerides including other esters and acids, ATC code: C10AX06.

• The Omega-3 series polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are essential fatty acids.
• OMACOR has an effect on serum lipids, causing a drop in triglyceride levels secondary to the drop in VLDL (very low density lipoproteins), as well as on hemostasis and blood pressure.
• OMACOR decreases hepatic triglyceride synthesis because EPA and DHA are poor substrates for triglyceride synthesis enzymes and inhibit the esterification of other fatty acids.
• The increased b- oxidation of fatty acids in hepatic peroxisomes also contributes to the decrease in triglycerides by reducing the amount of free fatty acids available for their synthesis. Inhibition of this synthesis leads to a decrease in VLDL.
• OMACOR increases LDL cholesterol in certain patients with hypertriglyceridemia. The increase in HDL-cholesterol levels is modest, significantly lower than that observed after administration of fibrates, and not constant.
• The long-term hypolipidemic effect (beyond 1 year) is not known.
• In addition, there is no formal proof that lowering triglycerides reduces coronary risk.
• During treatment with OMACOR, the production of thromboxane A2 is reduced and the bleeding time is slightly increased. No significant effect on other coagulation factors was observed.
• In the GISSI Prevenzione study, 11,324 patients with recent myocardial infarction ( < 3 months), and receiving recommended preventive treatment combined with a Mediterranean diet, were randomized to receive OMACOR (n = 2836), vitamin E (n = 2830), OMACOR + vitamin E (n = 2830) or no treatment (n = 2828). The GISSI-Prevenzione study is a multicenter, randomized, open-label study carried out in Italy.
• The results observed during the 3.5 years of follow-up with OMACOR 1 g / day showed a significant decrease in the first composite primary endpoint including all-cause mortality, non-fatal myocardial infarctions and non-fatal stroke (reduction in relative risk of 15% [2-26], p = 0.0226 in patients taking OMACOR alone compared to the control group, and 10% [1-18], p = 0.0482 in patients taking OMACOR in combination or not to vitamin E).
• A decrease in the components of the second predefined primary endpoint including cardiovascular mortality, non-fatal myocardial infarctions and non-fatal cerebrovascular accidents was demonstrated (reduction in the relative risk of 20% [5-32], p = 0.0082, in patients taking OMACOR alone compared to the control group, relative risk reduction of 11% [1-20%], p = 0.0526, in patients taking OMACOR combined or not with vitamin E).
• Secondary analysis of each of the components of the primary endpoints showed a significant decrease in all-cause mortality and cardiovascular mortality, without, however, showing any reduction in non-fatal cardiovascular events or fatal or non-fatal stroke.

How To Store omacor ?

• Keep this medication out of the sight and reach of children.
• Do not use OMACOR after the expiry date stated on the box and the bottle. The expiration date refers to the last day of that month.
• Store at a temperature not exceeding 25 ° C. Do not freeze.
• Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

omacor Side Effects

Like all medicines, OMACOR, soft capsule can cause side effects, although not everybody gets them.

The following side effects can happen with this medicine:

Common side effects (occurring in less than 1 in 10 people)

• digestive disorders and digestive difficulties (dyspepsia)
• nausea

Uncommon side effects (occurring in less than 1 in 100 people)

• pain in the stomach and abdomen
• allergic reactions
• dizziness
• loss or change in taste
• diarrhea
• vomiting

Rare side effects (occurring in less than 1 in 1,000 people)

• headache
• acne
• rash with itching (pruritus)
• high level of glucose (sugar) in the blood
• liver problems

Very rare side effects (occurring in less than 1 in 10,000 people)

• presence of blood in the stool
• low blood pressure
• nasal dryness
• red rash (hives)
• changes in the results of some blood tests

If you experience any of the side effects listed as serious, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

omacor Interactions

• If you are taking a medicine to stop a blood clot from forming without your arteries, such as warfarin, you may need to do additional blood tests and adjust your usual dose of anti-coagulant.
• If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

INTERACTIONS OF OMACOR WITH FOOD AND DRINK

• It is recommended to take the capsules with meals to reduce the risk of digestive disorders (gastrointestinal side effects).

Drive and use machines

• The effects on the ability to drive and use machines have not been studied. However Omacor is expected to have no or negligible influence on the ability to drive and use machines.

Warnings and Precautions

• if you are due to have surgery or have recently had one,
• if you have had an injury recently,
• if you have kidney problems
• if you have uncontrolled diabetes
• if you have liver problems. Your doctor will do blood tests to check the effects of this medicine on your liver.

If any of these apply to you, talk to your doctor or pharmacist before taking this medicine.

Use in the elderly

• Use OMACOR 1000 mg, soft capsule with caution if you are over 70 years old.

Use in children

• The use of OMACOR 1000 mg, soft capsule is not recommended in children.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

• There are insufficient data from the use of Omacor in pregnant women. Studies in animals have not shown reproductive toxicity.
• The potential risk in the clinic is not known and therefore Omacor should not be used during pregnancy unless clearly necessary.

Feeding with milk

• There are no data on the excretion of Omacor in milk in animals and in women. Omacor should not be used during breast-feeding.

Fertility

• There are insufficient data on the effect of Omacor on fertility.

What happens if I overdose from omacor ?

• If you accidentally take more of this medicine than you should, do not worry as it is unlikely to require special treatment.
• However, you should consult your doctor or pharmacist for advice.

What should I do if I miss a dose?

• If you have forgotten to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case take the next dose at the usual time.
• Do not take a double dose (twice the dose recommended by your doctor) to make up for the dose you forgot to take.

What happens if you stop taking omacor ?

• Not applicable.
• Not applicable.
• Not applicable.

If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

What is  Forms and Composition ?

SHAPES and PRESENTATIONS

• Soft capsule (oblong; transparent gelatin containing a pale yellow oil):   Bottle of 28.

COMPOSITION 

	p capsule
90 ethyl esters of omega-3 acids	1000 mg
(including 840 mg of eicosapentaenoic acid (EPA, as ethyl ester: 460 mg) and docosahexaenoic acid (DHA, as ethyl ester: 380 mg))

• Excipients: Soft capsule content: Alpha-tocopherol (antioxidant that can be mixed with soybean oil). Soft capsule shell: gelatin, glycerol, purified water, medium chain triglycerides, lecithin (soy).
• Excipient with known effect: soybean oil.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.